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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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Monthly Report: New Drug Approvals in China | August 2022
In August 2022, China NMPA approved 13 new drugs, including 9 chemical drugs and 4 biological products. Among them, MSD's HPV 9-valent vaccine got approval to expand the target group from females 16-26 years of age to 9-45 years of age.
Sep 09, 2022
INDUSTRY
China CDE to Grant Priority Review Designation to Sanofi's Avaglucosidase Alfa, a Rare Disease Therapy
Sanofi's avalglucosidase alfa entered the preliminary list of priority review designation on August 15, as shown on China CDE's website. If no objections are filed to CDE by August 22, the drug will officially be granted the priority review and can complete the technical review within 70 workdays, much shorter than 200 workdays for drugs without the priority review.
Aug 18, 2022
INDUSTRY
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Drug Registration
New Drug
COVID-19
Monthly Report: New Drug Approvals in China | July 2022
In July 2022, China NMPA approved 10 new drugs, including 8 chemical drugs and 2 biological products. Among the drugs, Genuine Biotech's Azvudine Tablets is the first homegrown oral drug to get NMPA’s approval for COVID-19 treatment.
Aug 05, 2022
INDUSTRY
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Cancer
Cardiovascular Disease
Rare Disease
Drug Registration
New Drug
Monthly Report: New Drug Approvals in China | March 2022
In March 2022, China NMPA approved 23 new drugs, including 15 chemical drugs and 8 biological products.
Apr 07, 2022
INDUSTRY
Multinational Pharma Companies Record Sales Growth in 2021
Johnson & Johnson ranks the first with global sales of 93.77 billion USD.
Pfizer has the most rapid growth in global sales, zooming up by 95% to 81.3 billion USD.
AstraZeneca is the largest foreign pharma company regarding its 5.99 billion USD sales in China.
MSD records the most vigorous sales growth in China of 60%, bringing the sales to 4.26 billion USD.
Mar 18, 2022
INDUSTRY
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Cancer
Drug Registration
New Drug
COVID-19
Monthly Report: New Drug Approvals in China | February 2022
In February 2022, China NMPA approved 16 new drugs, including 12 chemical drugs and 4 biological products. Among the newly approved drugs, Pfizer’s Paxlovid is the first foreign drug against COVID-19 to receive marketing authorization in China.
Mar 11, 2022